by Tyler Patchen and Kyle LaHucik – EndpointsNews
Above image caption: Chaim Lebovits, BrainStorm CEO
After a rare public rejection from the FDA last year, BrainStorm Cell Therapeutics is headed back to the regulator with what it claims is a “correction” to Phase III data for its ALS investigational therapy NurOwn.
The FDA rejected the treatment last year after it flunked primary and secondary goals in November 2020. From day one, the biotech has tried positioning the therapy, which uses stem cells to secrete nerve growth factors, as having a chance of success at the FDA despite the results. The biotech once again thinks there’s a chance at approval and is headed back to the FDA with a BLA, but there’s still a major fork in the road.
The drug didn’t pass the primary goal in the new analysis, either.
